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WO2003079929A2 - Bioprothese endovasculaire sans suture et procede et dispositif de fabrication de celle-ci - Google Patents

Bioprothese endovasculaire sans suture et procede et dispositif de fabrication de celle-ci Download PDF

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Publication number
WO2003079929A2
WO2003079929A2 PCT/US2003/008966 US0308966W WO03079929A2 WO 2003079929 A2 WO2003079929 A2 WO 2003079929A2 US 0308966 W US0308966 W US 0308966W WO 03079929 A2 WO03079929 A2 WO 03079929A2
Authority
WO
WIPO (PCT)
Prior art keywords
biomaterial
irradiating
energy
roll
sheath
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2003/008966
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English (en)
Other versions
WO2003079929A3 (fr
Inventor
Hua Xie
Lisa A. Buckley
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Providence Health System Oregon
Original Assignee
Providence Health System Oregon
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Providence Health System Oregon filed Critical Providence Health System Oregon
Priority to MXPA04009158A priority Critical patent/MXPA04009158A/es
Priority to AU2003220492A priority patent/AU2003220492A1/en
Priority to CA002480023A priority patent/CA2480023A1/fr
Priority to EP03716802A priority patent/EP1494617A2/fr
Publication of WO2003079929A2 publication Critical patent/WO2003079929A2/fr
Publication of WO2003079929A3 publication Critical patent/WO2003079929A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C67/00—Shaping techniques not covered by groups B29C39/00 - B29C65/00, B29C70/00 or B29C73/00
    • B29C67/0014—Shaping techniques not covered by groups B29C39/00 - B29C65/00, B29C70/00 or B29C73/00 for shaping tubes or blown tubular films
    • B29C67/0018—Turning tubes inside out
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C33/00—Moulds or cores; Details thereof or accessories therefor
    • B29C33/44—Moulds or cores; Details thereof or accessories therefor with means for, or specially constructed to facilitate, the removal of articles, e.g. of undercut articles
    • B29C33/48—Moulds or cores; Details thereof or accessories therefor with means for, or specially constructed to facilitate, the removal of articles, e.g. of undercut articles with means for collapsing or disassembling
    • B29C33/50—Moulds or cores; Details thereof or accessories therefor with means for, or specially constructed to facilitate, the removal of articles, e.g. of undercut articles with means for collapsing or disassembling elastic or flexible
    • B29C33/505—Moulds or cores; Details thereof or accessories therefor with means for, or specially constructed to facilitate, the removal of articles, e.g. of undercut articles with means for collapsing or disassembling elastic or flexible cores or mandrels, e.g. inflatable
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C35/00—Heating, cooling or curing, e.g. crosslinking or vulcanising; Apparatus therefor
    • B29C35/02—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould
    • B29C35/08—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould by wave energy or particle radiation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C53/00—Shaping by bending, folding, twisting, straightening or flattening; Apparatus therefor
    • B29C53/56—Winding and joining, e.g. winding spirally
    • B29C53/562—Winding and joining, e.g. winding spirally spirally
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/14—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation
    • B29C65/1403—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation characterised by the type of electromagnetic or particle radiation
    • B29C65/1406—Ultraviolet [UV] radiation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/14—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation
    • B29C65/1403—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation characterised by the type of electromagnetic or particle radiation
    • B29C65/1409—Visible light radiation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/14—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation
    • B29C65/1429—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation characterised by the way of heating the interface
    • B29C65/1454—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation characterised by the way of heating the interface scanning at least one of the parts to be joined
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/14—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation
    • B29C65/16—Laser beams
    • B29C65/1603—Laser beams characterised by the type of electromagnetic radiation
    • B29C65/1612—Infrared [IR] radiation, e.g. by infrared lasers
    • B29C65/1616—Near infrared radiation [NIR], e.g. by YAG lasers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/14—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation
    • B29C65/16—Laser beams
    • B29C65/1629—Laser beams characterised by the way of heating the interface
    • B29C65/1654—Laser beams characterised by the way of heating the interface scanning at least one of the parts to be joined
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
    • B29C66/05—Particular design of joint configurations
    • B29C66/10—Particular design of joint configurations particular design of the joint cross-sections
    • B29C66/11—Joint cross-sections comprising a single joint-segment, i.e. one of the parts to be joined comprising a single joint-segment in the joint cross-section
    • B29C66/114—Single butt joints
    • B29C66/1142—Single butt to butt joints
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
    • B29C66/05—Particular design of joint configurations
    • B29C66/10—Particular design of joint configurations particular design of the joint cross-sections
    • B29C66/12—Joint cross-sections combining only two joint-segments; Tongue and groove joints; Tenon and mortise joints; Stepped joint cross-sections
    • B29C66/122—Joint cross-sections combining only two joint-segments, i.e. one of the parts to be joined comprising only two joint-segments in the joint cross-section
    • B29C66/1222—Joint cross-sections combining only two joint-segments, i.e. one of the parts to be joined comprising only two joint-segments in the joint cross-section comprising at least a lapped joint-segment
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
    • B29C66/05—Particular design of joint configurations
    • B29C66/10—Particular design of joint configurations particular design of the joint cross-sections
    • B29C66/12—Joint cross-sections combining only two joint-segments; Tongue and groove joints; Tenon and mortise joints; Stepped joint cross-sections
    • B29C66/122—Joint cross-sections combining only two joint-segments, i.e. one of the parts to be joined comprising only two joint-segments in the joint cross-section
    • B29C66/1224—Joint cross-sections combining only two joint-segments, i.e. one of the parts to be joined comprising only two joint-segments in the joint cross-section comprising at least a butt joint-segment
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/40—General aspects of joining substantially flat articles, e.g. plates, sheets or web-like materials; Making flat seams in tubular or hollow articles; Joining single elements to substantially flat surfaces
    • B29C66/41—Joining substantially flat articles ; Making flat seams in tubular or hollow articles
    • B29C66/43—Joining a relatively small portion of the surface of said articles
    • B29C66/432—Joining a relatively small portion of the surface of said articles for making tubular articles or closed loops, e.g. by joining several sheets ; for making hollow articles or hollow preforms
    • B29C66/4322—Joining a relatively small portion of the surface of said articles for making tubular articles or closed loops, e.g. by joining several sheets ; for making hollow articles or hollow preforms by joining a single sheet to itself
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/40—General aspects of joining substantially flat articles, e.g. plates, sheets or web-like materials; Making flat seams in tubular or hollow articles; Joining single elements to substantially flat surfaces
    • B29C66/49—Internally supporting the, e.g. tubular, article during joining
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/40—General aspects of joining substantially flat articles, e.g. plates, sheets or web-like materials; Making flat seams in tubular or hollow articles; Joining single elements to substantially flat surfaces
    • B29C66/49—Internally supporting the, e.g. tubular, article during joining
    • B29C66/494—Internally supporting the, e.g. tubular, article during joining using an inflatable core
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/80—General aspects of machine operations or constructions and parts thereof
    • B29C66/83—General aspects of machine operations or constructions and parts thereof characterised by the movement of the joining or pressing tools
    • B29C66/836—Moving relative to and tangentially to the parts to be joined, e.g. transversely to the displacement of the parts to be joined, e.g. using a X-Y table
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2027/00—Use of polyvinylhalogenides or derivatives thereof as moulding material
    • B29K2027/12—Use of polyvinylhalogenides or derivatives thereof as moulding material containing fluorine
    • B29K2027/18—PTFE, i.e. polytetrafluorethene, e.g. ePTFE, i.e. expanded polytetrafluorethene
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2995/00—Properties of moulding materials, reinforcements, fillers, preformed parts or moulds
    • B29K2995/0037—Other properties
    • B29K2995/0056—Biocompatible, e.g. biopolymers or bioelastomers
    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor
    • B29L2031/7532—Artificial members, protheses
    • B29L2031/7534—Cardiovascular protheses

Definitions

  • the present disclosure is related to the field of stents, and more specifically to an implantable, sutureless bioprosthetic stent graft comprising a biomaterial.
  • the disclosure is further related to a device and a method for suturelessly bonding a biomaterial to a bioprosthetic frame of a stent graft.
  • Development of tissue substitutes has been undertaken for replacement and repair of damaged or diseased tissue and organs. Where there is a lack of native tissue, reconstruction generally is performed with an autograft, heterogaft and allograft.
  • tissue grafts and synthetic biomaterials typically have been unsuccessful based on mechanical, structure, functional, or biocompatibility problems. There is therefore no ideal biomaterial for tissue replacement, particularly for soft tissue and tubular organs (e.g., vascular, trachea, esophagus, and biliary tract, and urinary tracts tissue).
  • Stents have been used with some success to overcome the problems of restenosis or re-narrowing of a vessel wall. Stents are exemplified by U.S. Patent Nos. 6,293,968 (to Taheri) and 5,306,286 (to Stack et al.), which teaches a prosthetic stent constructed of synthetic materials. 6293968 and 5306286.
  • Bioprosthesis coverings to reduce the untoward effects of metallic device implantation, such as intimal hyperplasia, thrombosis and lack of native tissue incorporation.
  • Synthetic materials for stent coverings vary widely, e.g., materials such as Gore-Tex ® , polytetrafluoroethylene (PTFE), and a resorbable yarn fabric (U.S. Patent No. 5,697,969 to Schmitt et al.). Synthetic materials generally are not preferred substrates for cell growth. Biomaterials and biocompatible materials also have, been utilized in prostheses. Such attempts include a collagen-coated stent, taught in U.S. Patent No.
  • elastin has been identified as a candidate biomaterial for covering a stent (U.S. Patent No. 5,990,379 (to Gregory)).
  • collagen-rich biomaterials are believed to enhance cell repopulation and therefore reduce the negative in vivo effects of metallic stents. It is believed that small intestinal submucosa (SIS) is particularly effective in this regard.
  • Mechanically hardier stent graft devices are required in certain implantation sites, such as cardiovascular, aortic, or other locations.
  • a plurality of layers of biomaterial typically are used.
  • Suturing is a poor technique for joining multiple layers of biomaterial. While suturing is adequate to join the biomaterial sheets to the metallic frame, the frame-sutured multiple sheets are not joined on their major surfaces and are therefore subject to leakage between the layers.
  • Suturing of the major surfaces of the biomaterial layers also introduces holes into the major surfaces, increasing the risk of conduit fluid leaking through or a tear forming in one of the surfaces.
  • suture material can enhance the foreign body response and lead to tubular vessel narrowing at the implantation site.
  • U.S. Patent Nos. 5,147,514, 5,332,475, and 5,854,397 describe processes for photo-oxidizing collageneous material in the presence of a photo-catalyst to crosslink and stabilize the collageneous material.
  • Reconstituted soluble collagen fibrils are taught to be mixed and suspended in solutions containing a photo-catalyst, so that a photo-oxidizative cross-linking process can be performed to produce stabilized collagen products.
  • references fail to teach crosslinking of collagen fibrils between two individual native tissues, as well as fusion of those separate tissue pieces using photo-oxidization techniques.
  • Biocompatible adhesive compounds also have been investigated as alternatives to suturing.
  • fibrin glue a fibrinogen polymer polymerized with thrombin
  • Bioadhesives generally produce rigid, inflexible bond regions that can lead to local biomaterial tears and failure of the graft device.
  • some bioadhesives and photochemical cross-linking agents e.g., glutaraldehyde
  • carry risk of acute and chronic toxicity and biocompatibility e.g., glutaraldehyde
  • Bio-tissue welding using a laser, is known in the art, e.g., U.S. Patent No. 5,156,613 (to Sawyer). This technique uses light energy to heat an area of tissue sufficiently to denature at least a portion of the tissue constituents and fuse them together.
  • FIG. 1 is a perspective view of a sutureless bioprosthetic stent graft constructed according to the method disclosed herein.
  • FIGS. 2-3 are lateral and longitudinal cross-sectional views, respectively, of the valve graft of FIG. 1.
  • FIGS. 4-9 are diagrams of a method for constructing a sutureless bioprosthetic stent graft according to the present disclosure.
  • FIGS. 10-11 are side view diagrams of two embodiments of a device for manufacturing a sutureless bioprosthetic stent graft according to the disclosed method.
  • FIGS. 12 is a cutaway perspective diagram of a mandrel of the present device, having housed therein means for irradiating with energy.
  • FIGS. 1-3 A sutureless bioprosthetic stent graft according to the present disclosure is shown in FIGS. 1-3.
  • the stent graft 1 comprises a typically cylindrical stent frame 10 having a length L and defining a lumen 12.
  • the stent graft further has a sheath of biomaterial 20 suturelessly attached to and substantially covering the stent frame.
  • the stent frame 10 preferably is constructed of a fine-gauge metal (e.g., 0.014 inch diameter) of a flexible character. Such frame enables the stent graft to be expanded or compressed in diameter or length.
  • a fine-gauge metal e.g., 0.014 inch diameter
  • a stent frame of this type can be made of a shape memory material.
  • a shape memory wire frame is known in the art as a frame that substantially returns to its original shape after it is deformed and then released, as described in U.S. Pat. No. 4,512,338 (to Balko et al.).
  • Other materials can be effectively employed as the substrate for a stent frame, for example, a synthetic material such as TEFLON (polytetrafluoroethylene), DACRON or a biodegradable composition.
  • Alternative compositions can in some cases be of a memory character.
  • the stent frame is covered with a biomaterial sheath 20 having a selected thickness T.
  • the biomaterial sheath can comprise a single layer, a single layer with a partial overlap, or a plurality of layers (single or multiple sheets) coupled to the supporting stent frame.
  • the sheath of biomaterial preferably comprises both the inner stent graft surface 24 and the outer stent graft surface 26.
  • the biomaterial sheath is constructed of a plurality of layers of biomaterial
  • the plurality of layers of biomaterial can be positioned on the inner stent graft surface 24, the outer stent graft surface 26, or both inner and outer stent graft surfaces.
  • the biomaterial can be comprised of a natural or synthetic compound, and preferably is a collagen-rich material.
  • Suitable natural biomaterials include collagen, small intestine submucosa, pericardial tissue, and elastin. Combinations of the above biomaterials also can be envisioned.
  • the biomaterial can be synthetic, for example, TEFLON or DACRON coated with albumin or a collagen-containing substrate.
  • the biomaterial formed into a sheath is bonded to the stent frame without the use of conventional sutures. Avoidance of suture material mitigates the risk of a foreign body response by the host patient, a response that can lead to a narrowing of the tubular vessel in which the graft is implanted.
  • Such stent grafts might be used, for example, in the cardiovascular system (e.g., in an artery or vein), the gastrointestinal tract, the urinary tract, or the trachea.
  • the stent graft as disclosed permits fluid flow direction through the conduit while preventing leakage out of the conduit.
  • Implantation of a stent graft according to the present disclosure provides several benefits over prior art stents.
  • Collagen and SIS are known to provide a matrix that encourages native cell repopulation and may ultimately enhance tissue repair and regeneration as well as integration of implanted supporting structure materials.
  • a method for making a first embodiment of a bioprosthetic stent graft generally comprises wrapping a collagen-rich biomaterial on a mandrel to form a multi-layer structure thereon, and suturelessly bonding together the multiple layers of the biomaterial.
  • the method can be employed to produce a stent graft composed of a biomaterial and further comprising a synthetic stent frame.
  • a sheet of biomaterial 30 having a first edge 32, an inward-facing surface 34 and an outward-facing surface 36.
  • the biomaterial sheet can be comprised of a natural or synthetic compound, and preferably is a collagen-rich material.
  • SIS small intestine submucosa
  • Reconstructed SIS biomaterial can be obtained in accordance with the description in the prior US. Pat. No. 4,956,1 8 and 4,902,508.
  • the biomaterial can have incorporated therein a drug or other bio- active compound.
  • the incorporation of such compounds allows for the most efficacious delivery of the drug to the implantation site.
  • the biomaterial sheet 30 is wrapped on a mandrel 60 to form a biomaterial roll 40.
  • wrapping can be performed by approximating the first edge 32 of the biomaterial sheet 30 longitudinally along the mandrel 60, then rotating the mandrel.
  • the biomaterial roll 40 has a first major surface 42, a second major surface 44, a first end 46, and a second end 48.
  • a stent frame 10 then is positioned over the first major surface 42 of the biomaterial roll 40 and intermediate the first and second ends 46,48 of the biomaterial roll (FIG. 7).
  • the stent frame is shown being encased with the biomaterial in FIG. 8.
  • At least the first end 46 of the biomaterial roll 40 is everted back over the stent frame 10, covering and embedding it within the biomaterial roll.
  • the first end 46 can be approximated to the first major surface 42 of the biomaterial roll proximate the second end 48.
  • the first end 46 and the second end 48 both can be everted and folded back over the stent frame to encase the frame in biomaterial.
  • the first end and the second end of the biomaterial roll can be approximated to one another.
  • a second sheet of biomaterial can be laid over the stent frame to cover it and abut the second biomaterial sheet with the first major surface of the biomaterial roll.
  • suturelessly bonding comprises suturelessly bonding the first and second ends of the biomaterial to one another or to the first major surface 42 of the biomaterial roll 40.
  • Sutureless bonding can be accomplished using any one of a variety of mechanisms.
  • sutureless bonding is via thermal fusion.
  • the biomaterial roll is irradiated with energy 72 sufficient to at least partially thermally fuse the biomaterial sheet.
  • Sutureless bonding using thermal fusion preferably is carried out with a laser, most preferably emitting light having a wavelength of about 800 nm.
  • Alternative means for suturelessly bonding the biomaterial using thermal fusion techniques are known in the art.
  • Devices producing appropriate energy include a radio-frequency energy source, an ultrasound energy source, and contact electro-thermal transducer.
  • an energy-absorbing material can be utilized.
  • the energy-absorbing material typically is energy-absorptive within a predetermined range of light wavelengths.
  • An energy-absorbing material suitable for use with an 800nm laser is indocyanine green.
  • Tissue welding solder typically is a viscous proteinaceous fluid, such as an albumin solution.
  • Welding patches can be dried strips of albumin, collagen, elastin, or similar compounds.
  • the solder or welding patch can have incorporated therein an energy-absorbing material.
  • photo-chemical cross-linking alternatively can be employed to suturelessly bond the biomaterial.
  • a crosslinking agent is used, and cross-linking is accomplished by reacting the crosslinking agent to form attachments to the abutted pieces of biomaterial (e.g., the first and second ends, as described above).
  • a representative photo-chemical crosslinking step comprises treating the biomaterial with methylene blue, then irradiating the biomaterial roll with visible or ultraviolet light.
  • Sutureless bonding can be spatially limited to the abutted ends 46,48 of the biomaterial roll, but can also include irradiating selected loci on, or the entirety of, the first major surface 42, the second major surface 44, or both the first and second major surfaces 42,44 of the biomaterial roll 40.
  • Irradiating a plurality of loci on the biomaterial roll with energy can be facilitated by rotating the mandrel 60 during irradiating.
  • the biomaterial preferably is substantially dehydrated prior to suturelessly bonding.
  • This alternative step makes the biomaterial more self- adhesive (that is, "stickier"), which aids in retaining the biomaterial surface and edges in an approximated orientation. Further, dehydration enhances the optical transmission into the biomaterial, improving light-mediated sutureless bonding.
  • Substantial dehydration of the biomaterial is especially advantageous when sutureless bonding is via photo-crosslinking.
  • the biomaterial need not be substantially dehydrated, although removal of some fluid from the biomaterial is preferable.
  • rehydration typically proceeds contemporaneous with irradiating, that is, during and/or after sutureless bonding by irradiation of the biomaterial roll.
  • the suturelessly bonded biomaterial roll and encased stent frame then are removed from the mandrel. Removal generally is accomplished by sliding the stent graft 1 off the end of the mandrel 60.
  • the mandrel can be of an expandable or balloon-type construction, and can be deflated to assist in stent graft removal.
  • a device for manufacturing a sutureless bioprosthetic stent graft.
  • the device generally comprises a mandrel 60 and an energy- irradiating means 70.
  • the energy-irradiating means 70 and the mandrel 60 can be structurally combined.
  • the mandrel 60 preferably is a roughly cylindrical structure having a selected diameter D, adapted to have positioned on it a stent graft comprising a biomaterial sheath.
  • the diameter and shape of the mandrel can be customized to produce a sutureless stent graft having a desired lumen configuration.
  • the mandrel can have a constant diameter corresponding to the inner diameter of a cylindrical stent graft fabricated thereon.
  • the mandrel can be tapered, permitting formation thereon of a tapering sutureless stent graft.
  • the mandrel can have an increased or decreased central diameter, adapted to produce a stent graft with a central portion that is outwardly- or inwardly-bulging.
  • the mandrel can be constructed of a variety of materials, such as metal, plastic, or other rigid material.
  • the mandrel preferably is constructed of a material that is non-reactive to the energy outputted by the energy- irradiating means.
  • Wire or a flexible compound can be employed in the manufacture of a first alternative embodiment of the mandrel.
  • a wire mandrel can have a cage-like or coiled structure, providing sufficient structure for a biomaterial roll to be formed thereon.
  • a balloon-type mandrel can be utilized, as shown in FIGS. 7-9.
  • a balloon-type mandrel can be inflated to a selected diameter and a stent graft manufactured thereon, after which the mandrel is deflated to remove the stent graft.
  • the energy-irradiating means 70 is adapted to irradiate a biomaterial sheath with energy 72 when the biomaterial sheath is positioned on the mandrel 60. Irradiation results in suturelessly bonding via either a thermal bonding or photo-chemical crosslinking mechanism.
  • means for irradiating is configured to irradiate the first major surface 42 of a biomaterial roll 40 positioned on the mandrel 60.
  • Means for irradiating the biomaterial sheath with energy can be a light source, such as a white light source, or an ultraviolet source.
  • a light source such as a white light source, or an ultraviolet source.
  • Such light sources are especially suitable for photo-chemical crosslinking, using a photo-active crosslinking agent such as methylene blue.
  • a laser can be employed, preferably operative to emit light having a wavelength of about 800nm.
  • the laser is positioned to irradiate a biomaterial roll on the mandrel.
  • the energy-irradiating means can be an ultrasound energy source, a radio-frequency energy source, or a contact electro-thermal transducer.
  • means for irradiating 70 can be configured inside the mandrel 60 (FIG. 12). This configuration permits irradiation of the second major surface 44 of a biomaterial roll 40 positioned on the mandrel 60.
  • An irradiating means inside the mandrel can be employed as an alternative to, or in addition to, an external irradiating means to permit irradiation of the second major surface or both the first and second major surfaces, respectively, of a biomaterial roll.
  • the fiber-optic element 72 is housed at least partially within the mandrel 60.
  • the fiber-optic element is adapted to transmit light from a light source 70 to the mandrel, to irradiate the second major (or inward-facing) surface 44 of a biomaterial sheath positioned on the mandrel. Irradiating with energy can be undertaken by emitting light energy from the fiber tip positioned at one end of the biomaterial roll, and then advancing or retracting the fiber to reposition the fiber tip adjacent the desired locus for sutureless bonding thereat.
  • the device can further include means for moistening 80 a biomaterial sheath when said sheath is positioned on the mandrel. Moistening can be accomplished via an injecting or misting element 82 adapted to emit a mist of fluid or other appropriate moistening matter.
  • fluid 84 can be maintained in a well 86, with the mandrel positioned above said fluid. So oriented, the lower-most portion of the biomaterial roll 40 on the mandrel will contact the fluid and be wetted thereby.
  • moistening means 80 can be used to rehydrate the biomaterial roll 40. Rehydration can be accomplished by, for example, misting fluid onto the biomaterial roll, by controlling the level of the fluid so as to selectively contact the biomaterial roll with the fluid, or by raising and lowering the mandrel to bring the roll into or out of contact with the fluid.
  • Rotating means 90 for rotating the mandrel 60 further can be utilized to rotate a stent graft positioned on the mandrel. Rotating enables the entire outward-facing (first major) surface 42 of the biomaterial sheath to be accessible to the moistening means 80. Rotation of the mandrel further permits the energy-irradiating means

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Pulmonology (AREA)
  • Biomedical Technology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Mechanical Engineering (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne une bioprothèse endovasculaire qui comporte une structure d'endoprothèse et une gaine en biomatériau liée sans suture à ladite structure. La liaison sans suture permet d'éviter les sutures et de réduire sensiblement les complications médicales lors de l'implantation de l'endoprothèse. L'invention concerne de plus un dispositif et un procédé de fabrication de cette endoprothèse. Un mandrin est utilisé pour façonner l'endoprothèse, et des moyens pour irradier le biomatériau permettent de mettre en oeuvre la liaison sans suture.
PCT/US2003/008966 2002-03-21 2003-03-21 Bioprothese endovasculaire sans suture et procede et dispositif de fabrication de celle-ci Ceased WO2003079929A2 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
MXPA04009158A MXPA04009158A (es) 2002-03-21 2003-03-21 Endoprotesis bioprostetica sin suturas y metodo y dispositivo para su fabricacion.
AU2003220492A AU2003220492A1 (en) 2002-03-21 2003-03-21 Sutureless bioprosthetic stent and method and device for manufacturing same
CA002480023A CA2480023A1 (fr) 2002-03-21 2003-03-21 Bioprothese endovasculaire sans suture et procede et dispositif de fabrication de celle-ci
EP03716802A EP1494617A2 (fr) 2002-03-21 2003-03-21 Bioprothese endovasculaire sans suture et procede et dispositif de fabrication de celle-ci

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US10/104,391 2002-03-21
US10/104,391 US7166124B2 (en) 2002-03-21 2002-03-21 Method for manufacturing sutureless bioprosthetic stent

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WO2003079929A2 true WO2003079929A2 (fr) 2003-10-02
WO2003079929A3 WO2003079929A3 (fr) 2003-11-27

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EP (1) EP1494617A2 (fr)
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AU2003220492A8 (en) 2003-10-08
MXPA04009158A (es) 2004-11-26
WO2003079929A3 (fr) 2003-11-27
US20030181968A1 (en) 2003-09-25
US7166124B2 (en) 2007-01-23
CA2480023A1 (fr) 2003-10-02
AU2003220492A1 (en) 2003-10-08
EP1494617A2 (fr) 2005-01-12

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